BurnoutCARENCT05557981
The Impact of a Novel Coaching Program on Medical Errors and Well-Being of Physicians
A study testing Coaching in people with Burnout and Adverse Event, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This is a randomized controlled trial with a mixed method design to determine the impact of coaching on self-perceived medical errors, burnout, and resilience. The study team developed a novel coaching curriculum based in principles of positive psychology and self-reflection with the hypothesis that the coaching… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Burnout, Adverse Event, Medical Education
- What is being tested?
- Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Residents and fellows in a training program at Beth Israel Deaconess Medical Center (BIDMC)
- faculty members at BIDMC
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: A Randomized Controlled Trial on The Impact of a Novel Coaching Program on Medical Errors, Clinical Reasoning, and Well-Being of Physicians, or the CARE (Coaching to Advance Resilience and Reduce Error) Study
This is a randomized controlled trial with a mixed method design to determine the impact of coaching on self-perceived medical errors, burnout, and resilience. The study team developed a novel coaching curriculum based in principles of positive psychology and self-reflection with the hypothesis that the coaching intervention will lead to decreased medical errors, decreased burnout, and increased resilience in trainee and faculty participants. Resident and fellow trainees as well as faculty members were recruited across departments and randomized to coaching or control. Faculty in the coaching arm were trained in coaching techniques and paired with a trainee coachee. Survey results as well as focus groups will be used to analyze the impact of the coaching program as compared to standard mentorship (control).
- Conditions
- Burnout, Adverse Event, Medical Education
- Being tested
- Coaching
- Keywords
- Coaching, burnout, wellness, medical errors
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoachingBehavioural
A novel coaching curriculum based in positive psychology with an emphasis on self-reflection, goal setting and adverse event processing.
| Study group | Role | What they receive |
|---|---|---|
| Trainees - treatment | Experimental | Residents and fellows paired with a faculty coach from the "faculty - treatment" arm to participate in up to 4 coaching meetings Receives: Behavioral: Coaching |
| Trainees - control | No intervention | Residents and fellows randomized to the control arm. They are not paired with a faculty coach and instead continue to receive standard mentorship as part of their training program. |
| Faculty - treatment | Experimental | Faculty members randomized to receive coaching training and are paired with a resident/fellow from the "trainees - treatment" arm to conduct up to 4 coaching sessions over the course of the academic year. Receives: Behavioral: Coaching |
| Faculty - control | No intervention | Faculty members randomized to control arm. They are not paired with a trainee from this study and instead continue to provide mentorship as they typically would, as part of their role at an academic medical center |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical errors in trainees
Self-perceived medical errors amongst trainees based on survey response.
Measured: baseline (pre) compared to results at the end (post) of the coaching intervention, an average of 9 months
Burnout
Burnout score amongst trainees and faculty based on Stanford Professional Fulfillment Index
Measured: baseline (pre) compared to results at the end (post) of the coaching intervention, an average of 9 months
Resilience
Burnout score amongst trainees and faculty based on Connor Davidson Resilience Scale 2
Measured: baseline (pre) compared to results at the end (post) of the coaching intervention, an average of 9 months
Secondary outcomes (6)
medical errors in faculty
Self-perceived medical errors amongst faculty based on survey response. Specifically, faculty are asked "Do you think you may have made any medical error in the last 3 months? A medical error is the failure of a planned action to be completed as intended, or the failure of an unplanned action that should have been completed" with answer choices yes, no, and unsure.
Measured: baseline (pre) compared to results at the end (post) of the coaching intervention, an average of 9 months
delayed medical errors in faculty
Self-perceived medical errors amongst faculty based on survey response
Measured: baseline (beginning of study, before intervention) compared to 6 months post coaching program
Mechanism of change
Mechanism of change in burnout, resilience and medical errors in both trainees and faculty as compared to standard mentorship
Measured: assessed an average of 1 year after intervention initiation
Delayed Medical errors in trainees
Self-perceived medical errors amongst trainees based on survey response
Measured: up to 15 months
Burnout
Burnout score amongst trainees and faculty based on Stanford Professional Fulfillment Index
Measured: baseline (beginning of study, before intervention) compared to 6 months post coaching program
Delayed Resilience
Burnout score amongst trainees and faculty based on Connor-Davidson-RISC2
Measured: baseline (beginning of study, before intervention) compared to 6 months post coaching program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start10 Aug 2021
- Primary completion23 Jan 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnoutStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Risk Management Foundation
- Responsible party
- Principal investigator, Ritika S. Parris, Beth Israel Deaconess Medical Center
- Investigators
- Ritika Parris, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557981
- Sponsor's protocol ID
- 2021P000482
- Acronym
- CARE
- Status last verified
- Feb 2024
- First submitted
- 22 Sep 2022
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on The Impact of a Novel Coaching Program on Medical Errors, Clinical Reasoning, and Well-Being of Physicians, or the CARE (Coaching to Advance Resilience and Reduce Error) Study
- ClinicalTrials.gov ID
- NCT05557981
- Acronym / sponsor ID
- CARE / 2021P000482
- Conditions
- Burnout, Adverse Event, Medical Education
- Keywords
- Coaching, burnout, wellness, medical errors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Harvard Risk Management Foundation
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial with a mixed method design to determine the impact of coaching on self-perceived medical errors, burnout, and resilience. The study team developed a novel coaching curriculum based in principles of positive psychology and self-reflection with the hypothesis that the coaching intervention will lead to decreased medical errors, decreased burnout, and increased resilience in trainee and faculty participants. Resident and fellow trainees as well as faculty members were recruited across departments and randomized to coaching or control. Faculty in the coaching arm were trained in coaching techniques and paired with a trainee coachee. Survey results as well as focus groups will be used to analyze the impact of the coaching program as compared to standard mentorship (control).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Trainees - treatment | Experimental | Behavioral: CoachingResidents and fellows paired with a faculty coach from the "faculty - treatment" arm to participate in up to 4 coaching meetings |
| Trainees - control | No intervention | –Residents and fellows randomized to the control arm. They are not paired with a faculty coach and instead continue to receive standard mentorship as part of their training program. |
| Faculty - treatment | Experimental | Behavioral: CoachingFaculty members randomized to receive coaching training and are paired with a resident/fellow from the "trainees - treatment" arm to conduct up to 4 coaching sessions over the course of the academic year. |
| Faculty - control | No intervention | –Faculty members randomized to control arm. They are not paired with a trainee from this study and instead continue to provide mentorship as they typically would, as part of their role at an academic medical center |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Residents and fellows in a training program at Beth Israel Deaconess Medical Center (BIDMC)
- faculty members at BIDMC
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoachingA novel coaching curriculum based in positive psychology with an emphasis on self-reflection, goal setting and adverse event processing. | Behavioural | Faculty - treatment, Trainees - treatment |
Primary outcome
Medical errors in trainees
Time frame: baseline (pre) compared to results at the end (post) of the coaching intervention, an average of 9 months
Self-perceived medical errors amongst trainees based on survey response.
Burnout
Time frame: baseline (pre) compared to results at the end (post) of the coaching intervention, an average of 9 months
Burnout score amongst trainees and faculty based on Stanford Professional Fulfillment Index
Resilience
Time frame: baseline (pre) compared to results at the end (post) of the coaching intervention, an average of 9 months
Burnout score amongst trainees and faculty based on Connor Davidson Resilience Scale 2
6 secondary outcomes
medical errors in faculty
Time frame: baseline (pre) compared to results at the end (post) of the coaching intervention, an average of 9 months
delayed medical errors in faculty
Time frame: baseline (beginning of study, before intervention) compared to 6 months post coaching program
Mechanism of change
Time frame: assessed an average of 1 year after intervention initiation
Delayed Medical errors in trainees
Time frame: up to 15 months
Burnout
Time frame: baseline (beginning of study, before intervention) compared to 6 months post coaching program
Delayed Resilience
Time frame: baseline (beginning of study, before intervention) compared to 6 months post coaching program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ritika Parris, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coaching in people with Burnout and Adverse Event, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical errors in trainees (time frame: baseline (pre) compared to results at the end (post) of the coaching intervention, an average of 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.